New Topical Therapies for Onychomycosis

For more than 15 years the only available topical therapy for onychomycosis was ciclopirox, which offered rather low cure rates. In 2014 two new topical agents were approved: eficonazole (Jublia) and tavaborole (Kerydin).

Ciclopirox

Ciclopirox, available as an 8% nail lacquer, is indicated for treatment of mild to moderate onychomycosis. It is available as an 8% topical solution formulated as a nail lacquer. Ciclopirox is applied daily and then removed with alcohol weekly. Nail trimming is advised along with its use.

Two clinical studies evaluated the efficacy and safety of ciclopirox in more than 450 patients with onychomycosis of the great toenails.  After 48 weeks of application and monthly debridement of free nail, complete cure rates were 5.5% (vs 0.9% with vehicle) and 8.5% (vs 0% with vehicle) in the two studies, respectively. Mycological cure rates (i.e. negative fungal cultures) were 29% with ciclopirox vs 11% with vehicle and 36% with ciclopirox vs 9% with vehicle in the two studies, respectively. The most common adverse effects were application site reactions.

Efinaconazole (Jublia)

Efinaconazole, a triazole, was approved by the FDA in June 2014 for the treatment of onychomycosis of the toenails caused byT rubrum or T mentagrophytes. Efinaconazole is applied topically once daily for 48 weeks. Nail debridement is not required.

Clinical studies evaluated the efficacy of efinaconazole in more than 1600 patients with onychomycosis. Complete cure rates after 52 weeks 18.5% vs 4.7% with vehicle in data combined from two studies. Mycological cure rates at week 52 were  56.3% vs 16.6% with vehicle. Application site dermatitis and vesicles were the most commonly reported adverse events.

Tavaborole (Kerydin)

In July 2014 tavaborole, an oxaborole antifungal, was approved by the FDA for the treatment of onychomycosis of the toenails caused by T rubrum or T mentagrophytes. Tavaborole is applied once daily for 48 weeks. Debridement is not required.

The efficacy of tavaborole was evaluated in two clinical trials in almost 1200 patients. In the two studies, complete cure rates were 6.5% with tavaborole vs 0.5% with vehicle and 9.1% with tavaborole vs 1.5% vehicle, respectively. in the two studies, mycological cure rates were 31.1% with tavaborole vs 7.2% with vehicle and 35.9% with tavaborole vs 12.2% with vehicle, respectively.

Overall, the cure rates with these new vehicles is an advance over prior care. These topical treatments are an option for those unable to take oral antifungal medications, or may be useful adjuncts to oral or laser therapy.

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Tinea Unguium (Onychomycosis)

About tinea unguium (onychomycosis)

Tinea unguium, also known as onychomycosis, is infection of the nail—usually the distal nail bed—with a dermatophytic fungus. The usual culprits are Tricophyton rubrum and Tricophyton mentagrophytes, with T. rubrum being the most common cause of distal subungual onychomycosis. The nail appears discolored with areas of yellowish-brown or white. Involvement of the nail undersurface results in debris buildup and nail separation. Infection of the top surface leads to a brittle white surface. Involvement of the proximal nail plate is a sign of HIV infection.

Tinea unguium is a common problem, with prevalence increasing with age. The toenails are affected more frequently that the fingernails. The most common complaint is regarding the thickened unsightly appearance of the nail, but the condition can also cause pain or discomfort.

With what can tinea unguium be confused?

Nail disease is difficult to diagnose by appearance alone. The nail plate appearance of tinea unguium can be confused with the changes caused by psoriasis, trauma, or aging. Psoriasis will usually have other skin findings, and trauma can usually be identified by history.

How is tinea unguium diagnosed?

A KOH preparation and fungal culture confirms the diagnosis. Sometimes, a nail biopsy is required.

How is tinea unguium treated?

As is the case for tinea capitis, fungal infection of the nail cannot be eradicated with topical therapy; oral anti-fungal agents such as terbinafine (e.g. Lamisil) or itraconazole (e.g. Sporanox) are required for weeks to months, during which time the drug accumulates in the nail. Systemic antifungal agents have side-effects and the risk-benefit must be considered. Monitoring of hepatic enzymes and hematologic parameters is recommended. Since these drugs remain in the nail for months, retreatment should not be considered for six months for fingernails and 12 months for toenails.  Recently, some have proposed laser treatment as an option.

What is the prognosis for tinea unguium?

After a course of treatment, nails will still not appear completely normal. Tinea unguium is difficult to cure, and recurrence is common, especially for toenails.

More on tinea unguium (onychomycosis)

Image links

DermnetNZ: Fact sheet and photos

Other useful links

Blumberg, M and Kantor GR. Onychomycosis. e-medicine. APril 3, 2007

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